- BAT2206 is Bio-Thera Solutions’ third EC approved product
Guangzhou, China– August , 2024 –Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EC has approved BAT2206 (ustekinumab), a biosimilar referencing Stelara® following a positive opinion from the EMA’s CHMP on June 19, 2025. Gedeon Richter have rights to market BAT2206 in Europe under the brand name USYMRO®. BAT2206 is Bio-Thera’s third EC approved product.
“The EC approval of BAT2206 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s third EC approved product” said Shengfeng Li, CEO at Bio-Thera. “Bio-Thera is committed to expanding access for patients in Europe to important treatments through the continued development of our growing biosimilar pipeline of approved products.”
Bio-Thera and Gedeon Richter entered into a license and commercialization agreement for USYMRO® (BAT2206) in October of 2024. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product, and Gedeon Richter obtained exclusive rights to commercialize the medicine in the EU, the UK and Switzerland and selected other countries.
About USYMRO® (ustekinumab)
USYMRO® is a biosimilar to Janssen’s Stelara® which is a human monoclonal antibody that inhibits the bioactivity of human IL-12 and IL-23 by preventing shared p40 subunit from binding to the IL-12Rβ1 receptor chain of IL-12 (IL-12Rβ1/β2) and IL-23 (IL-12Rβ1/23R) receptor complexes on the surface of immune cells. IL-12 and IL-23 are involved in inflammatory and immune responses, such as natural killer cell activation, CD4+ T-cell differentiation and following relative cytokines stimulated release. Abnormal regulation of IL-12 and IL-23 have been implicated as important contributors to chronic inflammation, including psoriasis, psoriatic arthritis (PsA), and Crohn’s disease (CD). Neutralizing human IL-12 and IL-23 by USYMRO® to prevent the relevant cell signaling in the Th1 or Th17 lineages can effectively block the pathologic processes of these immune disorders.
About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and Usymro®(ustekinumab) in EU, and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to USYMRO® / BAT2206 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and high in vitro affinity may not translate to desired results in vivo or successful clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.
- USYMRO™ is a trademark of Gedeon Richter Plc
- STELARA® is a registered trademark of Johnson and Johnson
- QLETLI® is a registered trademark of Bio-Thera Solutions, Ltd.
- BETAGRIN® is a registered trademark of Bio-Thera Solutions, Ltd.
- STARJEMZA™ is a trademark of Hikma Pharmaceuticals.
- TOFIDENCE® is a trademark of N.V. Organon
- AVZIVI® is a registered trademark of Sandoz AG
- POBEVCY® is a registered trademark of Bio-Thera Solutions, Ltd.
